Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247987

Enrollment

140

Registered

2010-11-25

Start date

2010-12-31

Completion date

2015-04-30

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

IVF, assisted reproduction, embryo transfer

Brief summary

The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.

Detailed description

Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.

Interventions

PROCEDUREBlastocyst cryopreservation

Embryos cryopreserved at the blastocyst stage

PROCEDUREBipronuclear oocyte cryopreservation

Bipronuclear oocyte cryopreservation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1. Female patient seeking autologous in vitro fertilization (IVF) treatment. 2. Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l. 3. Baseline total antral follicle count observed on ultrasound with at least eight antral follicles. 4. 18 to 40 years of age. 5. Ability to read and understand English.

Exclusion criteria

1. Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)). 2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject. 3. No minors will be enrolled in this study.

Design outcomes

Primary

Measure	Time frame	Description
Ongoing pregnancy rate	10 weeks gestation	Ultrasonically confirmed fetal heart motion at 10 weeks gestation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026